Что такое врачебная ошибка

Говорить об ошибках в любой сфере деятельности человека трудно, а в медицине это особенно сложная задача. Такая ситуация связана с тем, что последствия недостаточно ответственного отношения врача к выполнению своей работы чрезвычайно серьезны — это недееспособность, инвалидность и даже смерть пациента. Особенность врачебной ошибки заключается в невозможности в определенной клинической ситуации для любого специалиста системы здравоохранения предусмотреть, а в дальнейшем предотвратить ее негативные последствия.

Актуальность проблемы врачебных ошибок имеет и  объективные предпосылки. Необходимо отметить резко возросшую активность современных методов диагностики и лечения, а также отрицательные стороны прогрессирующей специализации в медицине.

В научной литературе имеется множество подходов к объяснению сущности (определения) врачебной ошибки. При этом следует отметить, что до настоящего времени в юридической и медицинской науке не выработано общепринятое определение  понятия врачебная ошибка  равнозначно принятое как юристами, так и медицинскими работниками [1].

Большая медицинская энциклопедия определяет врачебные ошибки как «ошибки врача при исполнении своих профессиональных обязанностей, являющиеся следствием добросовестного заблуждения и не содержащие состава преступления или признаков проступков» [2].

Согласно малому энциклопедическому словарю Ф.А. Брокгауза и И.А. Ефрона, под ошибкой понимают нарушение формальной стороны мышления, разность между истинной величиной и полученным измерением [3].

В Толковом словаре современного русского языка С.И. Ожегова, под ошибкой понимается неправильность в действиях, мыслях [4].

В БМЭ от 1976 г. врачебные ошибки определяются как «ошибки врача при исполнении своих профессиональных обязанностей, являющиеся следствием добросовестного заблуждения и не содержащие состава преступления или признаков проступков» [5]. При этом не указывается, что именно послужило основанием добросовестного заблуждения медицинского работника и в чем взаимосвязь добросовестного заблуждения и состава преступления.

Анализ литературы по врачебным ошибкам показывает, что многочисленные определения врачебной ошибке в медицинской и юридической науках в той или иной степени базируются на точке зрения профессора И.В. Давыдовского. Он считал, что главным критерием врачебной ошибки является вытекающее из определенных объективных условий добросовестное заблуждение врача, основанное на несовершенстве современного состояния медицинской науки и методов исследования, на особом течении заболевания у определенного больного или на недостатке знаний и опыта врача, но без элементов халатности, небрежности и профессионального невежества. В отличие от врачебного проступка и от врачебного преступления врачебная ошибка не может быть заранее предусмотрена и предотвращена данным врачом, она не является результатом халатного отношения врача к своим обязанностям, следствием невежества или злоумышленного действия. Поэтому за врачебные ошибки, вне зависимости от их последствий, врач не может быть наказуем ни в дисциплинарном, ни в уголовном порядке» [6]. И.В. Давыдовский указывает на следующие аспекты в содержании понятия «врачебные ошибки».

Врачебные ошибки являются досадным браком, несчастным случаем  во врачебной деятельности. К сожалению, невозможно представить себе врача, даже немолодого, который не совершал бы диагностических и других профессиональных ошибок. Дело в необычной сложности объекта, с которым имеет дело медицина: «корни ошибок часто уходят за пределы личности врача» [7].

Несчастные случаи – это аномалия в клинической практике, когда врач все делал по правилам, но в силу бесконечной сложности объекта никак не мог предвидеть всех случайностей и неблагоприятного исхода. Иными словами, в моральном плане врачебные ошибки могут быть извинительны в силу стесненных, неоптимальных условий деятельности врача, исключительной сложности самой врачебной профессии. Однако наличие в медицинской практике ненаказуемых врачебных ошибок и несчастных случаев как неизбежных явлений, сопутствующих лечению, ни в коей мере не должно означать “права врача на ошибку”. Подобное “право” могло бы порождать элементарную профессиональную недобросовестность, за которой стоят обычно просмотренные диагнозы основного и сопутствующих заболеваний, недооценка хирургического риска, запоздалое оперативное вмешательство и др.  Если профессиональная деятельность врача заведомо ориентируется на ошибки, она утрачивает свою гуманистическую природу. Идея «права на ошибку» деморализует врачей. С позиций медицинской этики отношение к профессиональным ошибкам должны быть непримиримым.

При анализе врачебной ошибки необходимо четко различать незнание и невежество. Если незнание чего-либо не есть преступление, то иначе стоит вопрос в отношении проявления невежества. Если врач не знает элементарных основ анатомии, физиологии и клиники, он должен быть отстранен от работы. Вместе с тем, дифференцировать незнание от невежества не всегда возможно, считал И. Давыдовский. Поэтому любые врачебные ошибки он относил к «добросовестным заблуждениям».

Не случайно, поэтому в ряде научных статей, посвященных проблемам врачебных ошибок, невежество и незнание трактуются как разные понятия. Между тем в словаре русского языка С.И. Ожегова «невежество» обсуждается как отсутствие знаний или незнание. То есть, оба эти понятия являются тождественными. А халатность — это небрежность, недобросовестность в выполнении обязанностей [8].

Действительно, такие обстоятельства, как добросовестное  заблуждение, основанное на несовершенстве современного состояния медицинской науки и методов ее исследования, и добросовестное  заблуждение, вызванное особенностями течения заболевания определенного больного, не зависят от воли медицинского работника и не могут быть основанием для привлечения последнего к уголовной ответственности.

Однако добросовестное  заблуждение, объясняемое недостатками знаний, опыта врача, полностью зависит от воли медицинского работника. В каждом отдельном случае необходимо устанавливать уровень профессиональной подготовки врача, объем его знаний. На наш взгляд, элемент определения понятия «врачебная ошибка», касающийся «заблуждения, объясняемого недостатками знаний, опыта врача», является признаком, характеризующим неосторожную форму вины.

В вертикальном срезе границы компетентности неодинаковы, так как возможности начинающего врача и врача высшей квалификации, врача и фельдшера или медсестры различны. Там и тогда, где и когда лицо не усвоило знание, которое оно должно было и имело возможность усвоить, оно несет ответственность за незнание (невежество). Отсутствие данного понятия в законодательстве приводит к тому, что медицинские работники, считают «врачебную ошибку» только добросовестным заблуждением

Добросовестное заблуждение следует рассматривать исключительно в контексте с основаниями заблуждения, а также ограничивающими и объективно поддающимися установлению и проверке элементами, определяющими отсутствие умысла, ненадлежащего исполнения медицинским работником своих профессиональных обязанностей,  халатности и небрежности.

Халатность, невнимательность и медицинское невежество никак не связаны и не соприкасаются с добросовестным заблуждением врача, основанным на несовершенстве медицинской науки и ее методов, или атипичным течением заболевания. Что же касается недостаточности подготовки врача в совокупности с невнимательностью и медицинским невежеством, то это напрямую связано с неосторожной формой вины.

Аналогичной точки зрения придерживаются и О.Ю. Александрова, Н.Ф. Герасименко, Ю.И. Григорьев и И.К. Григорьев, согласно позиции которых врачебную ошибку следует считать явлением многофакторным. Суть этого явления заключается в том, что, с одной стороны, врачебная ошибка определяется результатом действия или бездействия врача, а с другой — оказанная медицинская помощь должна всегда быть надлежащего объема и содержания [9].

Признаками врачебной (медицинской) ошибки, по О.Ю. Александровой, Н.Ф. Герасименко, Ю.И. Григорьеву и И.К. Григорьеву, являются: •отрицательный результат при надлежащем объеме и содержании медицинской помощи; неправильное определение (ошибка мысли) при добросовестном заблуждении; •неправильное врачебное мероприятие (ошибка действия) при добросовестном заблуждении; •добросовестное заблуждение; при отсутствии халатности, умысла, неосторожности; •непреднамеренность нанесения вреда здоровью человека в связи с проведением оправданных диагностических, лечебных и профилактических мероприятий.

В данном случае во главу угла ставится отрицательный результат. Отрицательный результат при надлежащем объеме и содержании медицинской помощи, непреднамеренность нанесения вреда здоровью человека в связи с проведением оправданных диагностических, лечебных и профилактических мероприятий, на наш взгляд, напрямую соотносятся с добросовестным заблуждением, основанным на несовершенстве современного состояния медицинской науки и методов ее исследования и особенностях течения заболевания определенного больного. При этом указанные обстоятельства не зависят от воли медицинского работника и не могут быть основанием для привлечения последнего к уголовной ответственности.

Особенностью врачебной ошибки является невозможность для врача любой специальности ее предусмотреть, а в дальнейшем — предотвратить последствия. В англо-американской литературе в этих случаях применяется слово «непреднамеренность» [10].

Ряд ученых считают, что  понятие «врачебная ошибка» является составляющим другого понятия, более сложного и проблемного — «дефекты оказания медицинской помощи». По мнению В. В. Томилина и Ю. И. Соседко, основными причинами дефектов оказания медицинской помощи являются «недостаточная квалификация медицинских работников, отсутствие необходимой материально-технической базы и несоблюдение в ряде случаев санитарно-гигиенических норм. К одной из причин, по-видимому, следует отнести и неполноценный контроль со стороны органов управления здравоохранением и других служб…» [11].

По существу происходит смешение  понятий врачебная ошибка и дефект медицинской помощи. С этим нельзя  согласиться, считаем  эти понятия неоднородными. Для понимания различия этих терминов обратимся к грамматическому толкованию слова «дефект»: изъян, недостаток, недочет [12].

Налицо характерологические признаки качества и количества. Соответственно, под дефектом медицинской помощи подразумевается неоказание или некачественное оказание медицинской помощи: нарушения процесса диагностики, лечения или организации медицинской помощи, которые привели или могут привести к ухудшению здоровья пациента или наступлению смерти. Не случайно ряд ученых  отождествляют понятие «дефект медицинской помощи» с понятием «ненадлежащее оказание медицинской помощи».

Ряд специалистов считают [13], что врачебная ошибка, обусловленная безответственными действиями врача, халатностью, небрежностью, элементарной медицинской безграмотностью, нравственно-этической ущербностью, которые юридически классифицируются в качестве преступления или проступка, должна быть юридически наказуема. Между тем врачебная ошибка не подлежит наказанию, если она не содержит состава преступления и проступка и врач в пределах обязательных знаний своей профессии не мог ее предвидеть и предотвратить

Неправильные действия врача, в основе которой лежат субъективные причины (недостаточность подготовки врача в совокупности с невнимательностью, неадекватной  оценкой результатов  физикальных, лабораторно-аппаратных  или инструментальных методов исследования пациента, отсутствием  развитой культуры клинического мышления)  то это напрямую связано с неосторожной формой вины или можно определить как «медицинский деликт».

Деликт (от лат. delictum — нарушение, вина) — то же, что проступок (гражданское, административное, дисциплинарное правонарушение)  Деликт- незаконное действие, правонарушение, вызвавшее нанесение ущерба и влекущее за собой обязанность его возмещения.

Применение понятия «врачебная ошибка» возможно и необходимо только при наличии объективных причин ее возникновения. Такими причинами могут быть: неоптимальные условия работы врача, т.е.-отсутствие надлежащих условий оказания помощи (врач вынужден был оказывать помощь в таких условиях, где невозможно было оказать ее в соответствии со стандартами профессии; -неконтролируемые обстоятельства при оказании медицинской помощи; плохая материально-техническая оснащенность ЛПУ (например, невозможность проведения аппаратной вентиляции легких); несовершенство медицинской науки и ее методов и знаний (когда болезнь является малоизученной, и ошибка является следствием неполноты знаний не данного конкретного врача, а медицины в целом – например, болезнь Крейцфельдта-Якоба; недостаточный уровень профессиональной подготовки медицинского работника, без элементов преступной неосторожности, небрежности, халатности в его действиях (то есть, врач старался сделать все, что мог, но его знания и умения оказались недостаточными для правильных действий, например, стоматолог, оказывающий помощь новорожденному во время приступа вторичной асфиксии в отдаленном районе области);-чрезвычайная атипичность, редкость или злокачественность данного заболевания или его осложнения (например, натуральная оспа, молниеносное течение сепсиса);-индивидуальные особенности организма пациента (например, situs inversus viscerus totalis);

Сюда же, в качестве причин врачебных ошибок можно отнести ненадлежащие действия самого пациента, его родственников, других лиц (например, позднее обращение за медицинской помощью, отказ от госпитализации, уклонение, противодействие при осуществлении лечебно- диагностического процесса, нарушение режима лечения).

Таким образом, врачебная ошибка — это случайное стечение обстоятельств или следствие несовершенства медицинской науки и техники. Она не является результатом халатного, безответственного отношения врача к своим профессиональным обязанностям, невежества или преступного действия. То есть при возникновении такой ошибки вина врача отсутствует либо вообще нет состава преступления, следовательно, привлечения к правовой (гражданской или какой-либо другой) ответственности быть не может.

Можно видеть, что авторы, давая разные определения понятия «врачебная ошибка», сходятся в том, что при врачебной ошибке не наблюдается признаков умысла и неосторожности, а имеется заблуждение, связанное с различными причинами, и, в связи с этим, отмечается возникновение объективной неправильности деяния врача

По мнению Савицкой А.Н. и других авторов работы [14], посвященной проблеме врачебных ошибок,  врачебная ошибка сама по себе не может служить ни основанием ответственности, ни обстоятельством, исключающим ее. Только наличие вины лица, которое допустило врачебную ошибку, является основанием для привлечения его к гражданско-правовой ответственности. Согласно мнению одного из авторов, невозможность предсказания негативных результатов, которые находятся в причинно-следственной связи с противоправным поведением, в юридической литературе квалифицируется как случай (causes minor, казус). Он и выступает пределом ответственности. В связи с этим предусматривается разная степень ошибочности действий медицинских работников

Академик АМН России, профессор Ю.Д. Сергеев считает, что клиницисты имеют обоснованное право решать в пределах медицинской науки и практики вопросы о признании ошибок в лечебно-диагностическом процессе субъективными или объективными, а также о проведении их анализа, клинико-анатомической оценки. Однако решение вопроса о наличии или отсутствии в действиях медицинских работников элементов противоправности и виновности является прерогативой исключительно юристов, а не судебных медиков и клиницистов [15].

Юридическое понимание врачебной ошибки как неправильного действия  при выполнении медицинской манипуляции, которая в зависимости от степени общественной опасности, наличия неосторожной формы вины медицинского работника и вреда , причиненного здоровью пациента, исключает или приводит к возникновению различных видов юридической ответственности. Из данного определения можно заметить отличие понимания термина врачебной (медицинской) ошибки с позиции врачей и с позиции юристов, когда последние говорят об общественной опасности деяния и возможности ответственности за нее врачами.

Существующие нормативные акты действующего законодательства не определяют, как квалифицировать ошибочные (неправильные) действия медицинских работников. В правовой практике в случае установления ошибочности действий врачебного персонала приходится решать два вопроса: наличие (или отсутствие) вины в действиях врача, допустившего ошибку, и возможность юридической ответственности последнего в случае неправильной медицинской деятельности.

В одних случаях ошибкой называют противоправное виновное деяние медицинских работников, повлекшее причинение вреда здоровью пациента, в других — случайное невиновное причинение вреда, но главное отличие — это наличие или отсутствие вины.

Вместе с тем, заблуждение медицинского работника, объясняемое недостатками знаний, опыта, полностью зависит от воли медицинского работника и при установлении связи с медицинским невежеством, небрежностью, невнимательностью и наступлением вредного результата от последующих действий медицинского работника является признаком, характеризующим неосторожную форму вины. Установленные обстоятельства следует считать признаками элементов конкретного состава преступления (ч. 2 ст. 109 и ч. 2 ст. 118 УК РФ). Кроме того, медицинские работники несут ответственность в соответствии с законодательством Российской Федерации за нарушение прав в сфере охраны здоровья, причинения вреда жизни и (или) здоровья при оказании гражданам медицинской помощи. А возмещение вреда, причиненного жизни и /или  здоровью граждан, не освобождает медицинских работников от привлечения их к ответственности в соответствии с законодательством Российской Федерации [16].

Учитывая изложенное, мы приходим к выводу, что предложенные определения понятия «врачебная (медицинская) ошибка», в которых используется словосочетание «добросовестное заблуждение врача», при любом варианте добавления объективных характеристик, влияющих на установление преступности деяния, ставят лицо, ведущее расследование, в безвыходное положение, при котором доказать вину медицинского работника практически невозможно. Это обусловлено тем, что субъективная составляющая, выраженная словосочетанием «добросовестное заблуждение», фактически не подлежит опровержению.

Таким образом, если неправильные действия врача вызваны субъективными причинами: халатность, недобросовестное и ненадлежащее исполнение  врачом своих обязанностей, а так же неудовлетворительная организация деятельности медицинских учреждений, то это должно нести за собой уголовную ответственность. Если же неправильные  действия врача вызваны  объективными причинами, такими, как атипичное развитие болезни, недостаточная обеспеченность медицинских учреждений специалистами, оборудованием, лекарственными препаратами и т.п., то она не должна считаться преступлением и, следовательно, нести за собой уголовную ответственность.

Однако, разграничить врачебную ошибку от правонарушения в виде неосторожного виновного деяния (действия и/или бездействия) трудно, тем более, что размытость определений ошибки и неопределенность условий наступления ответственности (дисциплинарной, материальной, административной, гражданско-правовой, уголовной) «часто затрудняют правоприменительную практику

Врачебные ошибки могут быть нескольких видов. 1. Диагностические, т.е. связанные с постановкой диагноза. 2. Лечебно-тактические, сюда входят ошибки в выборе методов исследования и в оценке их результатов. 3. Лечебно-технические, это неполное обследование больного и ошибки диагностических или лечебных манипуляций. 4. Организационные, сюда включаются неправильная организация рабочего места и лечебного процесса. 5. Ошибки ведения медицинской документации. 6. Ошибки поведения медицинского персонала.

Анализ различных точек зрения на понятие врачебная ошибка позволил сформулировать авторскую  позицию по этому вопросу:

1.         Врачебная ошибка, врачебный проступок или преступление, дефект медицинской помощи – это неправильные действия врача при исполнении  своих профессиональных обязанностей, в основе которых лежат причины объективного или субъективного характера.

2.         Главным медико-этическим критерием врачебной ошибки ( неправильных действий)  выступает добросовестность (добросовестное заблуждение врача при оказании медицинской помощи). Добросовестность  определяет  качественный характер медицинской помощи, когда врач стремится максимально эффективно в соответствии с общепринятыми стандартами и правилами в современной медицине провести лечение пациента, но в силу объективных причин, независящих от врача, наступает неблагоприятный исход. Иными словами, врач по объективным причинам не мог предвидеть и предотвратить нежелательные результаты лечения пациента. В таком случае административно – правовая и уголовная ответственность не наступает.

Основным юридическим критерием  определения неправильных действий врача , за которыми следует административно-правовая или уголовная ответственность, выступает вина, мера  которой в свою очередь определяется степенью вреда причиненного пациенту при оказании медицинской помощи.

В методологическом аспекте при проведении юридического анализа ошибок существенное значение имеет четкое нормативное (легальное) определение профессиональной ошибки (неправильных действий) медицинского работника, которое, к сожалению, до настоящего времени отсутствует

3          В качестве методологического основания ( медико-этического и юридического) в определении врачебной ошибки лежит четкое выявление ее причин. Если  неправильные действия медицинского работника при оказании помощи пациенту были обусловлены  объективными, независящими от врача, причинами,  то в данном случае административно-правовая или уголовная ответственность не наступает.

4.         Когда речь идет о врачебном проступке, то здесь имеется в виду, что в основе неправильных действий в данном случае лежат: невнимательность, небрежность, отсутствие достаточного уровня профессиональных компетенций. Такие неправильные действия врача можно квалифицировать как неосторожную форму вины, когда врача несет административно-правовую или уголовную ответственность в зависимости от степени вины (мы имеем в виду степень причинения вреда пациенту при оказании медицинской помощи).

5          Говоря о врачебном преступлении, речь идет о том, что в данном случае в основе неправильных действий врача лежат такие причины, как халатность (как одно из преступлений против лица при выполнении  профессиональных обязанностей /ст.293 УК РФ/, недобросовестность, ненадлежащее выполнение своих профессиональных обязанностей. В этом случае возможна четкая и обоснованная юридическая квалификация действий врача и степень ответственности определяется степенью причиненного вреда пациенту.

6.         Что касается дефекта медицинской помощи, то мы рассматриваем  его как понятие, близкое по своему содержанию и критериям определения с понятием проступок или преступление.  По сути дефект медицинской помощи – это неправильные действия врача, обусловленные недобросовестным выполнением врачом своих профессиональных обязанностей при отсутствии прямого умысла причинения вреда больному.. По этой причине действия врача можно квалифицировать как правонарушение. Согласно Словарю С.И. Ожегова, под дефектом понимают какой-либо изъян, недостаток, недочет [17]. То есть, дефект является внешней характеристикой правонарушения,  соответствующий категории  «вред здоровью» и подлежит, тем самым,  определению в установленном законом порядке. Причем, не любой дефект является результатом ошибочных действий, так же как и не любые неправильные действия всегда приводят к неблагоприятному исходу, дефекту медицинской помощи. По-разному в связи с этим будут решаться и вопросы ответственности, в том числе – юридической.

И специалисты, и неспециалисты согласны, что врачебной ошибкой можно считать действие, имеющее негативный эффект для здоровья пациента, который, однако, не зависит от врача. Специалисты и представители следственных органов считают, что их количество можно снизить, если ввести обязательное страхование врачебной ошибки. Пациенты считают, что количество врачебных ошибок можно снизить, улучшив условия труда врачей. Все единодушны в том, что высокий уровень профессионализма гарантирует снижение числа врачебных ошибок.

В заключение отметим, что медицина является наиболее сложной формой человеческой деятельности, требующей, кроме специальных знаний и практических навыков, еще интуиции и высоких душевных качеств. На протяжении веков к представителям медицинской профессии предъявлялись требования о недопущении ошибок. Однако врачи ошибаются потому, что имеет дело с очень сложным человеческим организмом, ежедневно сталкиваются с нестандартными клиническими ситуациями и нередко это происходит в условиях отсутствия должного технологического обеспечения  в диагностики и лечения больных, оптимальных условий при оказании медицинской помощи, недостатка времени и объективной информации. Кроме этого, сама медицинская наука несовершенна.

Несмотря на наличие современных компьютеров, совершенных диагностических приборов, новейших лекарств с самым широким спектром действия, ошибки в профессиональной деятельности врача, очевидно, еще не скоро исчезнут. Самое главное для врача — не пытаться их скрыть, переложить на чьи-либо плечи. Необходимо отыскивать причину, породившую ошибку, и принять все меры для того, чтобы не допустить подобного в дальнейшем. «Только дураки учатся на своих ошибках, умные предпочитают учиться на ошибках других» — предупреждал О. Бисмарк.

Ошибки — неизбежные и печальные издержки лечебной работы, ошибки — это всегда плохо, и единственное оптимальное, что вытекает из трагедии врачебных ошибок, это то, что они по диалектике вещей учат и помогают тому, чтобы их не было. Они несут в существе своем науку о том, как не ошибаться. И виновен не тот врач, кто допустил ошибку, а тот, кто не свободен от трусости отстаивать ее». Эти слова принадлежат выдающемуся клиницисту-гематологу И.А. Кассирскому [18].

Подлежат ли гласности врачебные ошибки? Врачебные ошибки подлежат гласности в обязательном порядке. Великий хирург Н.И. Пирогов писал: «С самого начала своей практической деятельности я взял себе за правило никогда и ни в чем не скрывать ни малейшего промаха, ни одной своей ошибки. И чистый перед судом своей совести прошу мне указать: где и когда я скрыл хоть одну свою ошибку» [19].

Человек наделен правом на охрану своего здоровья Конституцией РФ, а принципы доступности и качества медицинской помощи регламентирует статья 10 Закона «Об основах охраны здоровья граждан». Однако, наличие особой ответственности, в процессе выполнения своей работы врачи совершают ошибки, которые возможны на любом этапе лечения. Такие ошибки могут стать следствием причинения вреда здоровью и жизни пациента.

Понятие врачебной ошибки: российское законодательство

• заражение пациента СПИДом, 
• незаконный аборт; 
• продажа фармацевтических препаратов без лицензии (если это ухудшило здоровье пациента). 

Опираясь на указанные статьи, можно сделать вывод, что ошибка врача может квалифицироваться по следующему составу:

• неоказание помощи пациенту; 
• причинение смерти по неосторожности; 
• причинение тяжкого вреда здоровью по неосторожности. 

Классификация врачебных ошибок в медицине

В медицине существует своя квалификация ошибок врачей, которая весьма обширна. В обобщенном варианте можно выделить шесть видов медицинских ошибок:

1. Диагностические – этап постановки диагноза; 
2. Лечебно-технические – это недостаточная либо ошибочная диагностика или лечение; 
3. Лечебно-тактические –это неверно подобранный метод исследования, который позволяет оставить диагноз, некорректная или неправильная интерпретация полученных результатов либо ошибка в выявлении показаний или противопоказаний к любому из методов терапии; 
4. Организационные – допускаются в случае неверно организованного терапевтического процесса или некачественных, неукомплектованных рабочих мест медицинских служащих; 
5. Неправильное оформление и ведение обязательной документации – в случае, если принятые в отношении пациента действия не были зафиксированы в письменном виде; 
6. Ненадлежащее поведение медицинских служащих – пренебрежение принципами этики и нормами морали в отношении пациентов. 

Официальной статистики медицинских ошибок в России не ведется, однако, по непроверенным данным в год из-за «промахов» врачей погибает около 300 000 пациентов. При этом на первом месте статистики ошибок – неправильный выбор лекарства для лечения и их дозировка – 56% из возможных 100%.

Виды ответственности за врачебные ошибки

Законодатель предусматривает несколько видов ответственности за небрежное отношение медицинских работников к своим обязанностям:

• дисциплинарную (осуществляется администрацией поликлиник или больниц, заключается в трудовых взаимоотношениях, например в виде отстранения от работы, выговоре или увольнении);
• гражданскую; 
• уголовную. 

Рассмотрим две последние ответственности более подробно.

Важно! Основная проблема юристов заключается в том, что доказать факт совершения виновных действий со стороны врача крайне сложно. Но при наличии соответствующих выводов независимых экспертов, неправильные действия врача могут подпасть под определенную статью Гражданского или Уголовного кодекса РФ.

Гражданская ответственность при врачебной ошибке

• лечение, включая санаторно-курортное;
• приобретение лекарственных средств; 
• уход специально нанятых людей; 
• приобретение специальных транспортных средств и приспособлений для передвижения, в случае лишения трудоспособности и/или получения инвалидности; 
• протезирование; 
• переобучение для подготовки другой профессии. 

Еще одна статья Гражданского кодекса – 151, предусматривает для пациента возможность получения компенсации морального вреда. Истец должен предъявить доказательства причинения ему физических и нравственных страданий, а также причинную связь между ними и причиненным ему вредом.

Важно! Норма гражданского законодательства предусматривает презумпцию вины для причинителя вреда, то есть именно медицинский работник или его работодатель должны доказать, что вред был причинен не по его вине, что очень актуально при рассмотрении требований пациента.

Уголовная ответственность при врачебной ошибке

Уголовные дела при медицинских ошибках возбуждаются крайне редко, к ответственности привлекается непосредственно медицинский работник. Суть проблемы в том, что Уголовный кодекс РФ не содержит в себе прямой статьи, которая бы предусматривала конкретную норму ответственности за совершение врачебной ошибки. Поэтому юристы руководствуются составами нескольких отдельных статей, связанных с причинением человеку вреда здоровья и смерти:

• Часть 2 статьи 109 УК РФ — предусматривает уголовную ответственность за причинение смерти человеку по неосторожности, инкриминируется в случае ненадлежащего исполнения медицинским работником своих обязанностей. 
• Часть 2 статьи 118 УК РФ – предусматривает уголовную ответственность за причинение тяжкого вреда здоровью человека. 
• Часть 2 статьи 124 УК РФ – устанавливает ответственность за бездействие в виде неоказания больному соответствующей помощи. 
• Часть 4 статьи 122 УК РФ – предусматривает наказание за заражение пациента ВИЧ инфекцией в результате ненадлежащего исполнения врачом своих обязанностей. 
• Часть 1 статьи 235 УК РФ – устанавливает ответственность за занятие медицинской практикой без лицензии. 
• Часть 3 статьи 123 УК РФ – предусматривает ответственность за незаконное осуществление аборта. 
• Часть 2 статьи 293 УК РФ – предусматривает возможность привлечь врача за халатность действий в результате выполнения возложенных на него трудовых функций. 

Важно! Уголовная ответственность может наступить только в том случае, если будет доказана причинно-следственная связь между наступлением последствий и действиями врача, что в большинстве случаев очень сложно доказать.

Куда обратиться в случае врачебной ошибки

Важно! Возможность компенсации может рассматриваться и как в рамках гражданского судопроизводства, так и в рамках уголовного дела.

Срок исковой давности по врачебной ошибке

A medical error is a preventable adverse effect of care («iatrogenesis»), whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, behavior, infection, or other ailment.

Definitions[edit]

The word error in medicine is used as a label for nearly all of the clinical incidents that harm patients. Medical errors are often described as human errors in healthcare.^[1] Whether the label is a medical error or human error, one definition used in medicine says that it occurs when a healthcare provider chooses an inappropriate method of care, improperly executes an appropriate method of care, or reads the wrong CT scan. It has been said that the definition should be the subject of more debate. For instance, studies of hand hygiene compliance of physicians in an ICU show that compliance varied from 19% to 85%.^{[2][needs update]} The deaths that result from infections caught as a result of treatment providers improperly executing an appropriate method of care by not complying with known safety standards for hand hygiene are difficult to regard as innocent accidents or mistakes.

There are many types of medical error, from minor to major,^[3] and causality is often poorly determined.^{[4][needs update]}

There are many taxonomies for classifying medical errors.^[5]

Definitions of diagnostic error[edit]

There is no single definition of diagnostic error, reflecting in part the dual nature of the word diagnosis, which is both a noun (the name of the assigned disease; diagnosis is a label) and a verb (the act of arriving at a diagnosis; diagnosis is a process). At the present time, there are at least 4 definitions of diagnostic error in active use:

Graber et al. defined diagnostic error as a diagnosis that is wrong, egregiously delayed, or missed altogether.^[6] This is a ‘label’ definition, and can only be applied in retrospect, using some gold standard (for example, autopsy findings or a definitive laboratory test) to confirm the correct diagnosis. Many diagnostic errors fit several of these criteria; the categories overlap.

There are two process-related definitions: Schiff et al. defined diagnostic error as any breakdown in the diagnostic process, including both errors of omission and errors of commission.^[7] Similarly, Singh et al. defined diagnostic error as a ‘missed opportunity’ in the diagnostic process, based on retrospective review.^[8]

In its landmark report, Improving Diagnosis in Health Care, The National Academy of Medicine proposed a new, hybrid definition that includes both label- and process-related aspects: «A diagnostic error is failure to establish an accurate and timely explanation of the patient’s health problem(s) or to communicate that explanation to the patient.»^[9] This is the only definition that specifically includes the patient in the definition wording.

Impact[edit]

A 2000 Institute of Medicine report estimated that medical errors result in between 44,000 and 98,000 preventable deaths and 1,000,000 excess injuries each year in U.S. hospitals.^[10][11][12] In the UK, a 2000 study found that an estimated 850,000 medical errors occur each year, costing over £2 billion.^[13]

Some researchers questioned the accuracy of the IOM study, criticizing the statistical handling of measurement errors in the report,^[14] significant subjectivity in determining which deaths were «avoidable» or due to medical error, and an erroneous assumption that 100% of patients would have survived if optimal care had been provided.^[15] A 2001 study in the Journal of the American Medical Association of seven Department of Veterans Affairs medical centers estimated that for roughly every 10,000 patients admitted to the select hospitals, one patient died who would have lived for three months or more in good cognitive health had «optimal» care been provided.^[15]

A 2006 follow-up to the IOM study found that medication errors are among the most common medical mistakes, harming at least 1.5 million people every year. According to the study, 400,000 preventable drug-related injuries occur each year in hospitals, 800,000 in long-term care settings, and roughly 530,000 among Medicare recipients in outpatient clinics. The report stated that these are likely to be conservative estimates. In 2000 alone, the extra medical costs incurred by preventable drug-related injuries approximated $887 million—and the study looked only at injuries sustained by Medicare recipients, a subset of clinic visitors. None of these figures take into account lost wages and productivity or other costs.^[16]

According to a 2002 Agency for Healthcare Research and Quality report, about 7,000 people were estimated to die each year from medication errors – about 16 percent more deaths than the number attributable to work-related injuries (6,000 deaths).^{[citation needed]} Medical errors affect one in 10 patients worldwide. One extrapolation suggests that 180,000 people die each year partly as a result of iatrogenic injury.^[17] One in five Americans (22%) report that they or a family member have experienced a medical error of some kind.^[18]

The World Health Organization registered 14 million new cases and 8.2 million cancer-related deaths in 2012. It estimated that the number of cases could increase by 70% through 2032. As the number of cancer patients receiving treatment increases, hospitals around the world are seeking ways to improve patient safety, to emphasize traceability and raise efficiency in their cancer treatment processes.^[19]

Difficulties in measuring frequency of errors[edit]

About 1% of hospital admissions result in an adverse event due to negligence.^[20] However, mistakes are likely much more common, as these studies identify only mistakes that led to measurable adverse events occurring soon after the errors. Independent review of doctors’ treatment plans suggests that decision-making could be improved in 14% of admissions; many of the benefits would have delayed manifestations.^[21] Even this number may be an underestimate. One study suggests that adults in the United States receive only 55% of recommended care.^[22] At the same time, a second study found that 30% of care in the United States may be unnecessary.^[23] For example, if a doctor fails to order a mammogram that is past due, this mistake will not show up in the first type of study.^[20] In addition, because no adverse event occurred during the short follow-up of the study, the mistake also would not show up in the second type of study^[21] because only the principal treatment plans were critiqued. However, the mistake would be recorded in the third type of study. If a doctor recommends an unnecessary treatment or test, it may not show in any of these types of studies.

Cause of death on United States death certificates, statistically compiled by the Centers for Disease Control and Prevention (CDC), are coded in the International Classification of Disease (ICD), which does not include codes for human and system factors.^[24][25]

Causes[edit]

The research literature showed that medical errors are caused by errors of commission and errors of omission.^[26] Errors of omission are made when providers did not take action when they should have, while errors of commission occur when decisions and action are delayed.^[26] Commission and omission errors have also been attributed with communication failures.^[27][28]

Medical errors can be associated with inexperienced physicians and nurses, new procedures, extremes of age, and complex or urgent care.^[29] Poor communication (whether in one’s own language or, as may be the case for medical tourists, another language), improper documentation, illegible handwriting, spelling errors, inadequate nurse-to-patient ratios, and similarly named medications are also known to contribute to the problem.^[30][31] Misdiagnosis may be associated with individual characteristics of the patient or due to the patient multimorbidity.^[32][33] Patient actions or inactions may also contribute significantly to medical errors.^[28][27]

Healthcare complexity[edit]

Complicated technologies,^[34][35] powerful drugs, intensive care, rare and multiple diseases,^[36] and prolonged hospital stay can contribute to medical errors.^[37]

Complexity makes diagnosis especially challenging. There are less than 200 symptoms listed in Wikipedia,^[38] but there are probably more than 10,000 known diseases. The World Health Organization’s system for the International Classification of Disease, 9th Edition from 1979 listed over 14,000 diagnosis codes.^[39] Textbooks of medicine often describe the most typical presentations of a disease, but in many conditions patients may have variable presentations instead of the classical signs and symptoms. To add complexity, the signs and symptoms of a given condition change over time; in the early stages the signs and symptoms may be absent or minimal, and then these evolve as the condition progresses. Diagnosis is often challenging in infants and children who can’t clearly communicate their symptoms, and in the elderly, where signs and symptoms may be muted or absent.^[40]

There are more than 7000 rare diseases alone, and in aggregate these are not uncommon: Roughly 1 in 17 patients will be diagnosed with a rare disease over their lifetime.^[41] Physicians may have only learned a handful of these during their education and training.

System and process design[edit]

In 2000, The Institute of Medicine released «To Err is Human,» which asserted that the problem in medical errors is not bad people in health care—it is that good people are working in bad systems that need to be made safer.^[10]

Poor communication and unclear lines of authority of physicians, nurses, and other care providers are also contributing factors.^[42] Disconnected reporting systems within a hospital can result in fragmented systems in which numerous hand-offs of patients results in lack of coordination and errors.^[43]

Other factors include the impression that action is being taken by other groups within the institution, reliance on automated systems to prevent error.,^[44] and inadequate systems to share information about errors, which hampers analysis of contributory causes and improvement strategies.^[45]
Cost-cutting measures by hospitals in response to reimbursement cutbacks can compromise patient safety.^[46]
In emergencies, patient care may be rendered in areas poorly suited for safe monitoring. The American Institute of Architects has identified concerns for the safe design and construction of health care facilities.^[47]
Infrastructure failure is also a concern. According to the WHO, 50% of medical equipment in developing countries is only partly usable due to lack of skilled operators or parts. As a result, diagnostic procedures or treatments cannot be performed, leading to substandard treatment.

The Joint Commission’s Annual Report on Quality and Safety 2007 found that inadequate communication between healthcare providers, or between providers and the patient and family members, was the root cause of over half the serious adverse events in accredited hospitals.^[48] Other leading causes included inadequate assessment of the patient’s condition, and poor leadership or training.

Competency, education, and training[edit]

Variations in healthcare provider training & experience^[42][49] and failure to acknowledge the prevalence and seriousness of medical errors also increase the risk.^[50][51] The so-called July effect occurs when new residents arrive at teaching hospitals, causing an increase in medication errors according to a study of data from 1979 to 2006.^[52][53]

Human factors and ergonomics[edit]

Cognitive errors commonly encountered in medicine were initially identified by psychologists Amos Tversky and Daniel Kahneman in the early 1970s. Jerome Groopman, author of How Doctors Think, says these are «cognitive pitfalls», biases which cloud our logic. For example, a practitioner may overvalue the first data encountered, skewing their thinking. Another example may be where the practitioner recalls a recent or dramatic case that quickly comes to mind, coloring the practitioner’s judgement. Another pitfall is where stereotypes may prejudice thinking.^[54] Pat Croskerry describes clinical reasoning as an interplay between intuitive, subconscious thought (System 1) and deliberate, conscious rational consideration (System 2). In this framework, many cognitive errors reflect over-reliance on System 1 processing, although cognitive errors may also sometimes involve System 2.^[55]

Sleep deprivation has also been cited as a contributing factor in medical errors.^[13] One study found that being awake for over 24 hours caused medical interns to double or triple the number of preventable medical errors, including those that resulted in injury or death.^[56] The risk of car crash after these shifts increased by 168%, and the risk of near miss by 460%.^[57] Interns admitted falling asleep during lectures, during rounds, and even during surgeries.^[57] Night shifts are associated with worse surgeon performance during laparoscopic surgeries.^[13]

Practitioner risk factors include fatigue,^[58][59][60]
depression,^[61] and burnout.^[62]
Factors related to the clinical setting include diverse patients, unfamiliar settings, time pressures, and increased patient-to-nurse staffing ratio increases.^[63]
Drug names that look alike or sound alike are also a problem.^[64]

Errors in interpreting medical images are often perceptual instead of «fact-based»; these errors are often caused by failures of attention or vision.^[65] For example, visual illusions can cause radiologists to misperceive images.^[66]

A number of Information Technology (IT) systems have been developed to detect and prevent medication errors, the most common type of medical errors.^[67] These systems screen data such as ICD-9 codes, pharmacy and laboratory data. Rules are used to look for changes in medication orders, and abnormal laboratory results that may be indicative of medication errors and/or adverse drug events.^[68]

Examples[edit]

Errors can include misdiagnosis or delayed diagnosis, administration of the wrong drug to the wrong patient or in the wrong way, giving multiple drugs that interact negatively, surgery on an incorrect site, failure to remove all surgical instruments, failure to take the correct blood type into account, or incorrect record-keeping. A 10th type of error is ones which are not watched for by researchers, such as RNs failing to program an IV pump to give a full dose of IV antibiotics or other medication.

Errors in diagnosis[edit]

According to a 2016 study from Johns Hopkins Medicine, medical errors are the third-leading cause of death in the United States.^[69] The projected cost of these errors to the U.S. economy is approximately $20 billion, 87% of which are direct increases in medical costs of providing services to patient affected by medical errors.^[70] Medical errors can increase average hospital costs by as much as $4,769 per patient.^[71] One common type of medical error stems from x-rays and medical imaging: failing to see or notice signs of disease on an image.^[65] The retrospective «miss» rate among abnormal imaging studies is reported to be as high as 30% (the real-life error rate is much lower, around 4-5%, because not all images are abnormal),^[72] and up to 20% of missed findings result in long-term adverse effects.^[73][74]

A large study reported several cases where patients were wrongly told that they were HIV-negative when the physicians erroneously ordered and interpreted HTLV (a closely related virus) testing rather than HIV testing. In the same study, >90% of HTLV tests were ordered erroneously.^[75]
It is estimated^{[by whom?]} that between 10 and 15% of physician diagnoses are erroneous.^[76]

Misdiagnosis of lower extremity cellulitis is estimated to occur in 30% of patients, leading to unnecessary hospitalizations in 85% and unnecessary antibiotic use in 92%. Collectively, these errors lead to between 50,000 and 130,000 unnecessary hospitalizations and between $195 and $515 million in avoidable health care spending annually in the United States.^[77]

Misdiagnosis of psychological disorders[edit]

Female sexual desire sometimes used to be diagnosed as female hysteria.^{[citation needed]}

Sensitivities to foods and food allergies risk being misdiagnosed as the anxiety disorder orthorexia.

Studies have found that bipolar disorder has often been misdiagnosed as major depression. Its early diagnosis necessitates that clinicians pay attention to the features of the patient’s depression and also look for present or prior hypomanic or manic symptomatology.^[78]

The misdiagnosis of schizophrenia is also a common problem. There may be long delays of patients getting a correct diagnosis of this disorder.^[79]

Delayed sleep phase disorder is often confused with: psychophysiological insomnia; depression; psychiatric disorders such as schizophrenia, ADHD or ADD; other sleep disorders; or school refusal. Practitioners of sleep medicine point out the dismally low rate of accurate diagnosis of the disorder, and have often asked for better physician education on sleep disorders.^[80]

Cluster headaches are often misdiagnosed, mismanaged, or undiagnosed for many years; they may be confused with migraine, «cluster-like» headache (or mimics), CH subtypes, other TACs ( trigeminal autonomic cephalalgias), or other types of primary or secondary headache syndrome.^[81] Cluster-like head pain may be diagnosed as secondary headache rather than cluster headache.^[82] Under-recognition of CH by health care professionals is reflected in consistent findings in Europe and the United States that the average time to diagnosis is around seven years.^[83]

Asperger syndrome and autism tend to get undiagnosed or delayed recognition and delayed diagnosis^[84][85] or misdiagnosed.^[86] Delayed or mistaken diagnosis can be traumatic for individuals and families; for example, misdiagnosis can lead to medications that worsen behavior.^[87][88]

The DSM-5 field trials included «test-retest reliability» which involved different clinicians doing independent evaluations of the same patient—a new approach to the study of diagnostic reliability.^[89]

Outpatient vs. inpatient[edit]

Misdiagnosis is the leading cause of medical error in outpatient facilities.
Since the National Institute of Medicine’s 1999 report, «To Err is Human,» found up to 98,000 hospital patients die from preventable medical errors in the U.S. each year, government and private sector efforts have focused on inpatient safety.

Medical prescriptions[edit]

While in 2000 the Committee on Quality of Health Care in America affirmed medical mistakes are an «unavoidable outcome of learning to practice medicine»,^[90] at 2019 the commonly accepted link between prescribing skills and clinical clerkships was not yet demonstrated by the available data^[91] and in the U.S. legibility of handwritten prescriptions has been indirectly responsible for at least 7,000 deaths annually.^[92]

Prescription errors concern ambiguous abbreviations, the right spelling of the full name of drugs: improper use of the nomenclature, of decimal points, unit or rate expressions; legibility and proper instructions; miscalculations of the posology (quantity, route and frequency of administration, duration of the treatment, dosage form and dosage strength); lack of information about patients (e.g. allergy, declining renal function) or reported in the medical document.^[91] There were an estimated 66 million clinically significant medication errors in the British NHS in 2018. The resulting adverse drug reactions are estimated to cause around 700 deaths a year in England and to contribute to around 22,000 deaths a year. The British researchers did not find any evidence that error rates were lower in other countries, and the global cost was estimated at $42 billion per year.^[93]

Medication errors in hospital include omissions, delayed dosing and incorrect medication administrations. Medication errors are not always readily identified, but can be reported using case note reviews or incident reporting systems.^[94] There are pharmacist-led interventions that can reduce the incident of medication error.^[95] Electronic prescribing has been shown to reduce prescribing errors by up to 30%.^[96]

After an error has occurred[edit]

Mistakes can have a strongly negative emotional impact on the doctors who commit them.^{[97][98][99][100]}

Recognizing that mistakes are not isolated events[edit]

Some physicians recognize that adverse outcomes from errors usually do not happen because of an isolated error and actually reflect system problems.^[49] This concept is often referred to as the Swiss Cheese Model.^[101] This is the concept that there are layers of protection for clinicians and patients to prevent mistakes from occurring. Therefore, even if a doctor or nurse makes a small error (e.g. incorrect dose of drug written on a drug chart by doctor), this is picked up before it actually affects patient care (e.g. pharmacist checks the drug chart and rectifies the error).^[101] Such mechanisms include:
Practical alterations (e.g.-medications that cannot be given through IV, are fitted with tubing which means they cannot be linked to an IV even if a clinician makes a mistake and tries to),^[102] systematic safety processes (e.g. all patients must have a Waterlow score assessment and falls assessment completed on admission),^[102] and training programmes/continuing professional development courses^[102] are measures that may be put in place.

There may be several breakdowns in processes to allow one adverse outcome.^[103] In addition, errors are more common when other demands compete for a physician’s attention.^{[104][105][106]} However, placing too much blame on the system may not be constructive.^[49]

Placing the practice of medicine in perspective[edit]

Essayists imply that the potential to make mistakes is part of what makes being a physician rewarding and without this potential the rewards of medical practice would be diminished. Laurence states that «Everybody dies, you and all of your patients. All relationships end. Would you want it any other way? […] Don’t take it personally»^[107]
Seder states «[…] if I left medicine, I would mourn its loss as I’ve mourned the passage of my poetry. On a daily basis, it is both a privilege and a joy to have the trust of patients and their families and the camaraderie of peers. There is no challenge to make your blood race like that of a difficult case, no mind game as rigorous as the challenging differential diagnosis, and though the stakes are high, so are the rewards.»^[108]

Disclosing mistakes[edit]

Forgiveness, which is part of many cultural traditions, may be important in coping with medical mistakes.^[109] Among other healing processes, it can be accomplished through the use of communicative disclosure guidelines.^[110]

To oneself[edit]

Inability to forgive oneself may create a cycle of distress and increased likelihood of a future error.^[111]

However, Wu et al. suggest «…those who coped by accepting responsibility were more likely to make constructive changes in practice, but [also] to experience more emotional distress.»^[112] It may be helpful to consider the much larger number of patients who are not exposed to mistakes and are helped by medical care.^[108]

To patients[edit]

Gallagher et al. state that patients want «information about what happened, why the error happened, how the error’s consequences will be mitigated, and how recurrences will be prevented.»^[113] Interviews with patients and families reported in a 2003 book by Rosemary Gibson and Janardan Prasad Singh, put forward that those who have been harmed by medical errors face a «wall of silence» and «want an acknowledgement» of the harm.^[114] With honesty, «healing can begin not just for the patients and their families but also the doctors, nurses and others involved.» In a line of experimental investigations, Annegret Hannawa et al. developed evidence-based disclosure guidelines under the scientific «Medical Error Disclosure Competence (MEDC)» framework.^[110][115]

A 2005 study by Wendy Levinson of the University of Toronto showed surgeons discussing medical errors used the word «error» or «mistake» in only 57 percent of disclosure conversations and offered a verbal apology only 47 percent of the time.^[116]

Patient disclosure is important in the medical error process. The current standard of practice at many hospitals is to disclose errors to patients when they occur. In the past, it was a common fear that disclosure to the patient would incite a malpractice lawsuit. Many physicians would not explain that an error had taken place, causing a lack of trust toward the healthcare community. In 2007, 34 states passed legislation that precludes any information from a physician’s apology for a medical error from being used in malpractice court (even a full admission of fault).^[117] This encourages physicians to acknowledge and explain mistakes to patients, keeping an open line of communication.

The American Medical Association’s Council on Ethical and Judicial Affairs states in its ethics code:

«Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all facts necessary to ensure understanding of what has occurred. Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.»

From the American College of Physicians Ethics Manual:^[118]

«In addition, physicians should disclose to patients information about procedural or judgment errors made in the course of care if such information is material to the patient’s well-being. Errors do not necessarily constitute improper, negligent, or unethical behavior, but failure to disclose them may.»

However, «there appears to be a gap between physicians’ attitudes and practices regarding error disclosure. Willingness to disclose errors was associated with higher training level and a variety of patient-centered attitudes, and it was not lessened by previous exposure to malpractice litigation».^[119] Hospital administrators may share these concerns.^[120]

Consequently, in the United States, many states have enacted laws excluding expressions of sympathy after accidents as proof of liability.

Disclosure may actually reduce malpractice payments.^[121][122]

To non-physicians[edit]

In a study of physicians who reported having made a mistake, it was offered that disclosing to non-physician sources of support may reduce stress more than disclosing to physician colleagues.^[123] This may be due to the finding that of the physicians in the same study, when presented with a hypothetical scenario of a mistake made by another colleague, only 32% of them would have unconditionally offered support. It is possible that greater benefit occurs when spouses are physicians.^[124]

To other physicians[edit]

Discussing mistakes with other physicians is beneficial.^[49] However, medical providers may be less forgiving of one another.^[124] The reason is not clear, but one essayist has admonished, «Don’t Take Too Much Joy in the Mistakes of Other Doctors.»^[125]

To the physician’s institution[edit]

Disclosure of errors, especially ‘near misses’ may be able to reduce subsequent errors in institutions that are capable of reviewing near misses.^[126] However, doctors report that institutions may not be supportive of the doctor.^[49]

Use of rationalization to cover up medical errors[edit]

Based on anecdotal and survey evidence, Banja^[127] states that rationalization (making excuses) is very common among the medical profession to cover up medical errors.

By potential for harm to the patient[edit]

In a survey of more than 10,000 physicians in the United States, when asked the question, «Are there times when it’s acceptable to cover up or avoid revealing a mistake if that mistake would not cause harm to the patient?», 19% answered yes, 60% answered no and 21% answered it depends. On the question, «Are there times when it is acceptable to cover up or avoid revealing a mistake if that mistake would potentially or likely harm the patient?», 2% answered yes, 95% answered no and 3% answered it depends.^[128]

Cause-specific preventive measures[edit]

Traditionally, errors are attributed to mistakes made by individuals, who then may be penalized. A common approach to respond to and prevent specific errors is requiring additional checks at particular points in the system, whose findings and detail of execution must be recorded. As an example, an error of free flow IV administration of heparin is approached by teaching staff how to use the IV systems and to use special care in setting the IV pump. While overall errors become less likely, the checks add to workload and may in themselves be a cause of additional errors. In some hospitals, a regular morbidity and mortality conference meeting is scheduled to discuss complications or deaths and learn from or improve the overall processes.

A newer model for improvement in medical care takes its origin from the work of W. Edwards Deming in a model of Total Quality Management. In this model, there is an attempt to identify the underlying system defect that allowed the error to occur. As an example, in such a system the error of free flow IV administration of heparin is dealt with by not using IV heparin and substituting subcutaneous administration of heparin, obviating the entire problem. However, such an approach presupposes available research showing that subcutaneous heparin is as effective as IV. Thus, most systems use a combination of approaches to the problem.

In specific specialties[edit]

The field of medicine that has taken the lead in systems approaches to safety is anaesthesiology.^[129] Steps such as standardization of IV medications to 1 ml doses, national and international color-coding standards, and development of improved airway support devices has the field a model of systems improvement in care.

Pharmacy professionals have extensively studied the causes of errors in the prescribing, preparation, dispensing and administration of medications. As far back as the 1930s, pharmacists worked with physicians to select, from many options, the safest and most effective drugs available for use in hospitals.^[130] The process is known as the Formulary System and the list of drugs is known as the Formulary. In the 1960s, hospitals implemented unit dose packaging and unit dose drug distribution systems to reduce the risk of wrong drug and wrong dose errors in hospitalized patients;^[131] centralized sterile admixture services were shown to decrease the risks of contaminated and infected intravenous medications;^[132][133] and pharmacists provided drug information and clinical decision support directly to physicians to improve the safe and effective use of medications.^[134] Pharmacists are recognized experts in medication safety and have made many contributions that reduce error and improve patient care over the last 50 years. More recently, governments have attempted to address issues like patient-pharmacist communication and consumer knowledge through measures like the Australian Government’s Quality Use of Medicines policy.

Legal procedure[edit]

Standards and regulations for medical malpractice vary by country and jurisdiction within countries. Medical professionals may obtain professional liability insurances to offset the risk and costs of lawsuits based on medical malpractice.

Prevention[edit]

Medical care is frequently compared adversely to aviation; while many of the factors that lead to errors in both fields are similar, aviation’s error management protocols are regarded as much more effective.^[135] Safety measures include informed consent, the availability of a second practitioner’s opinion, voluntary reporting of errors, root cause analysis, reminders to improve patient medication adherence, hospital accreditation, and systems to ensure review by experienced or specialist practitioners.^[136]

A template has been developed for the design (both structure and operation) of hospital medication safety programmes, particularly for acute tertiary settings,^[137] which emphasizes safety culture, infrastructure, data (error detection and analysis), communication and training.

Particularly to prevent the medication errors in the perspective of the intrathecal administration of local anaesthetics, there is a proposal to change the presentation and packaging of the appliances and agents used for this purpose. One spinal needle with a syringe prefilled with the local anaesthetic agents may be marketed in a single blister pack, which will be peeled open and presented before the anaesthesiologist conducting the procedure.^[138]

Physician well-being has also been recommended as an indicator of healthcare quality given its association with patient safety outcomes.^[139] A meta-analysis involving 21517 participants found that physicians with depressive symptoms had a 95% higher risk of reporting medical errors and that the association between physician depressive symptoms and medical errors is bidirectional ^[61]

Reporting requirements[edit]

In the United States, adverse medical event reporting systems were mandated in just over half (27) of the states as of 2014, a figure unchanged since 2007.^[140][141] In U.S. hospitals error reporting is a condition of payment by Medicare.^[142] An investigation by the Office of Inspector General, Department of Health and Human Services released January 6, 2012 found that most errors are not reported and even in the case of errors that are reported and investigated changes are seldom made which would prevent them in the future. The investigation revealed that there was often lack of knowledge regarding which events were reportable and recommended that lists of reportable events be developed.^[143]

Misconceptions[edit]

Some common misconceptions about medical error include:

• Medical error is the «third leading cause of death» in the United States. This canard stems from an erroneous 2016 study which, according to David Gorski, «has taken on a life of its own» and fuelled «a myth promulgated by both quacks and academics».^[144]
• «Bad apples» or incompetent health care providers are a common cause. (Although human error is commonly an initiating event, the faulty care delivery process invariably permits or compounds the harm and so is the focus of improvement.)^[12]
• High-risk procedures or medical specialties are responsible for most avoidable adverse events. (Although some mistakes, such as in surgery, are harder to conceal, errors occur in all levels of care.^[12] Even though complex procedures entail more risk, adverse outcomes are not usually due to error, but to the severity of the condition being treated.)^[42][145] However, United States Pharmacopeia has reported that medication errors during the course of a surgical procedure are three times more likely to cause harm to a patient than those occurring in other types of hospital care.^[43]
• If a patient experiences an adverse event during the process of care, an error has occurred. (Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from the treatment itself.)^[10]

See also[edit]

References[edit]

Further reading[edit]

• Gawande, Atul (2002). Complications: A Surgeon’s Notes on an Imperfect Science. New York: Metropolitan Books. ISBN 978-0-8050-6319-6.
• Wachter, Robert; Shojania, Kaveh (2004). Internal Bleeding: The Truth Behind America’s Terrifying Epidemic of Medical Mistakes. New York: Rugged Land. ISBN 978-1-59071-016-6.
• Banja, John (2005). Medical Errors and Medical Narcissism. Boston: Jones and Bartlett. ISBN 978-0-7637-8361-7.
• Porter, Michael E.; Olmsted Teisberg, Elizabeth (2006). Redefining Health Care: Creating Value-Based Competition on Results. Boston: Harvard Business School Press. ISBN 978-1-59139-778-6.
• Gibson, Rosemary; Prasad Singh, Janardan (2003). Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans. Washington D.C.: Regnery. ISBN 978-0-89526-112-0.
• Alldred D.P.; Standage C.; Zermansky A.G.; Jesson B.; Savage I.; Franklin B.D.; Barber N.; Raynor D.K. (2008). «Development and validation of criteria to identify medication-monitoring errors in care home residents». International Journal of Pharmacy Practice. 16 (5): 317–323. doi:10.1211/ijpp.16.5.0007. S2CID 71701489.
• Committee on Identifying and Preventing Medication Errors; Board on Health Care Services (2007). Preventing medication errors. National Academies Press. ISBN 978-0-309-10147-9.
• Tewari, A.; Palm, B.; Hines, T.; Royer, T.; Alexander, E. (2014). «VEINROM: A possible solution for erroneous intravenous drug administration». Journal of Anaesthesiology Clinical Pharmacology. 30 (2): 263–266. doi:10.4103/0970-9185.130055. PMC 4009652. PMID 24803770.

A medical error is a preventable adverse effect of care («iatrogenesis»), whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, behavior, infection, or other ailment.

Definitions[edit]

The word error in medicine is used as a label for nearly all of the clinical incidents that harm patients. Medical errors are often described as human errors in healthcare.^[1] Whether the label is a medical error or human error, one definition used in medicine says that it occurs when a healthcare provider chooses an inappropriate method of care, improperly executes an appropriate method of care, or reads the wrong CT scan. It has been said that the definition should be the subject of more debate. For instance, studies of hand hygiene compliance of physicians in an ICU show that compliance varied from 19% to 85%.^{[2][needs update]} The deaths that result from infections caught as a result of treatment providers improperly executing an appropriate method of care by not complying with known safety standards for hand hygiene are difficult to regard as innocent accidents or mistakes.

There are many types of medical error, from minor to major,^[3] and causality is often poorly determined.^{[4][needs update]}

There are many taxonomies for classifying medical errors.^[5]

Definitions of diagnostic error[edit]

There is no single definition of diagnostic error, reflecting in part the dual nature of the word diagnosis, which is both a noun (the name of the assigned disease; diagnosis is a label) and a verb (the act of arriving at a diagnosis; diagnosis is a process). At the present time, there are at least 4 definitions of diagnostic error in active use:

Graber et al. defined diagnostic error as a diagnosis that is wrong, egregiously delayed, or missed altogether.^[6] This is a ‘label’ definition, and can only be applied in retrospect, using some gold standard (for example, autopsy findings or a definitive laboratory test) to confirm the correct diagnosis. Many diagnostic errors fit several of these criteria; the categories overlap.

There are two process-related definitions: Schiff et al. defined diagnostic error as any breakdown in the diagnostic process, including both errors of omission and errors of commission.^[7] Similarly, Singh et al. defined diagnostic error as a ‘missed opportunity’ in the diagnostic process, based on retrospective review.^[8]

In its landmark report, Improving Diagnosis in Health Care, The National Academy of Medicine proposed a new, hybrid definition that includes both label- and process-related aspects: «A diagnostic error is failure to establish an accurate and timely explanation of the patient’s health problem(s) or to communicate that explanation to the patient.»^[9] This is the only definition that specifically includes the patient in the definition wording.

Impact[edit]

A 2000 Institute of Medicine report estimated that medical errors result in between 44,000 and 98,000 preventable deaths and 1,000,000 excess injuries each year in U.S. hospitals.^[10][11][12] In the UK, a 2000 study found that an estimated 850,000 medical errors occur each year, costing over £2 billion.^[13]

Some researchers questioned the accuracy of the IOM study, criticizing the statistical handling of measurement errors in the report,^[14] significant subjectivity in determining which deaths were «avoidable» or due to medical error, and an erroneous assumption that 100% of patients would have survived if optimal care had been provided.^[15] A 2001 study in the Journal of the American Medical Association of seven Department of Veterans Affairs medical centers estimated that for roughly every 10,000 patients admitted to the select hospitals, one patient died who would have lived for three months or more in good cognitive health had «optimal» care been provided.^[15]

A 2006 follow-up to the IOM study found that medication errors are among the most common medical mistakes, harming at least 1.5 million people every year. According to the study, 400,000 preventable drug-related injuries occur each year in hospitals, 800,000 in long-term care settings, and roughly 530,000 among Medicare recipients in outpatient clinics. The report stated that these are likely to be conservative estimates. In 2000 alone, the extra medical costs incurred by preventable drug-related injuries approximated $887 million—and the study looked only at injuries sustained by Medicare recipients, a subset of clinic visitors. None of these figures take into account lost wages and productivity or other costs.^[16]

According to a 2002 Agency for Healthcare Research and Quality report, about 7,000 people were estimated to die each year from medication errors – about 16 percent more deaths than the number attributable to work-related injuries (6,000 deaths).^{[citation needed]} Medical errors affect one in 10 patients worldwide. One extrapolation suggests that 180,000 people die each year partly as a result of iatrogenic injury.^[17] One in five Americans (22%) report that they or a family member have experienced a medical error of some kind.^[18]

The World Health Organization registered 14 million new cases and 8.2 million cancer-related deaths in 2012. It estimated that the number of cases could increase by 70% through 2032. As the number of cancer patients receiving treatment increases, hospitals around the world are seeking ways to improve patient safety, to emphasize traceability and raise efficiency in their cancer treatment processes.^[19]

Difficulties in measuring frequency of errors[edit]

About 1% of hospital admissions result in an adverse event due to negligence.^[20] However, mistakes are likely much more common, as these studies identify only mistakes that led to measurable adverse events occurring soon after the errors. Independent review of doctors’ treatment plans suggests that decision-making could be improved in 14% of admissions; many of the benefits would have delayed manifestations.^[21] Even this number may be an underestimate. One study suggests that adults in the United States receive only 55% of recommended care.^[22] At the same time, a second study found that 30% of care in the United States may be unnecessary.^[23] For example, if a doctor fails to order a mammogram that is past due, this mistake will not show up in the first type of study.^[20] In addition, because no adverse event occurred during the short follow-up of the study, the mistake also would not show up in the second type of study^[21] because only the principal treatment plans were critiqued. However, the mistake would be recorded in the third type of study. If a doctor recommends an unnecessary treatment or test, it may not show in any of these types of studies.

Cause of death on United States death certificates, statistically compiled by the Centers for Disease Control and Prevention (CDC), are coded in the International Classification of Disease (ICD), which does not include codes for human and system factors.^[24][25]

Causes[edit]

The research literature showed that medical errors are caused by errors of commission and errors of omission.^[26] Errors of omission are made when providers did not take action when they should have, while errors of commission occur when decisions and action are delayed.^[26] Commission and omission errors have also been attributed with communication failures.^[27][28]

Medical errors can be associated with inexperienced physicians and nurses, new procedures, extremes of age, and complex or urgent care.^[29] Poor communication (whether in one’s own language or, as may be the case for medical tourists, another language), improper documentation, illegible handwriting, spelling errors, inadequate nurse-to-patient ratios, and similarly named medications are also known to contribute to the problem.^[30][31] Misdiagnosis may be associated with individual characteristics of the patient or due to the patient multimorbidity.^[32][33] Patient actions or inactions may also contribute significantly to medical errors.^[28][27]

Healthcare complexity[edit]

Complicated technologies,^[34][35] powerful drugs, intensive care, rare and multiple diseases,^[36] and prolonged hospital stay can contribute to medical errors.^[37]

Complexity makes diagnosis especially challenging. There are less than 200 symptoms listed in Wikipedia,^[38] but there are probably more than 10,000 known diseases. The World Health Organization’s system for the International Classification of Disease, 9th Edition from 1979 listed over 14,000 diagnosis codes.^[39] Textbooks of medicine often describe the most typical presentations of a disease, but in many conditions patients may have variable presentations instead of the classical signs and symptoms. To add complexity, the signs and symptoms of a given condition change over time; in the early stages the signs and symptoms may be absent or minimal, and then these evolve as the condition progresses. Diagnosis is often challenging in infants and children who can’t clearly communicate their symptoms, and in the elderly, where signs and symptoms may be muted or absent.^[40]

There are more than 7000 rare diseases alone, and in aggregate these are not uncommon: Roughly 1 in 17 patients will be diagnosed with a rare disease over their lifetime.^[41] Physicians may have only learned a handful of these during their education and training.

System and process design[edit]

In 2000, The Institute of Medicine released «To Err is Human,» which asserted that the problem in medical errors is not bad people in health care—it is that good people are working in bad systems that need to be made safer.^[10]

Poor communication and unclear lines of authority of physicians, nurses, and other care providers are also contributing factors.^[42] Disconnected reporting systems within a hospital can result in fragmented systems in which numerous hand-offs of patients results in lack of coordination and errors.^[43]

Other factors include the impression that action is being taken by other groups within the institution, reliance on automated systems to prevent error.,^[44] and inadequate systems to share information about errors, which hampers analysis of contributory causes and improvement strategies.^[45]
Cost-cutting measures by hospitals in response to reimbursement cutbacks can compromise patient safety.^[46]
In emergencies, patient care may be rendered in areas poorly suited for safe monitoring. The American Institute of Architects has identified concerns for the safe design and construction of health care facilities.^[47]
Infrastructure failure is also a concern. According to the WHO, 50% of medical equipment in developing countries is only partly usable due to lack of skilled operators or parts. As a result, diagnostic procedures or treatments cannot be performed, leading to substandard treatment.

The Joint Commission’s Annual Report on Quality and Safety 2007 found that inadequate communication between healthcare providers, or between providers and the patient and family members, was the root cause of over half the serious adverse events in accredited hospitals.^[48] Other leading causes included inadequate assessment of the patient’s condition, and poor leadership or training.

Competency, education, and training[edit]

Variations in healthcare provider training & experience^[42][49] and failure to acknowledge the prevalence and seriousness of medical errors also increase the risk.^[50][51] The so-called July effect occurs when new residents arrive at teaching hospitals, causing an increase in medication errors according to a study of data from 1979 to 2006.^[52][53]

Human factors and ergonomics[edit]

Cognitive errors commonly encountered in medicine were initially identified by psychologists Amos Tversky and Daniel Kahneman in the early 1970s. Jerome Groopman, author of How Doctors Think, says these are «cognitive pitfalls», biases which cloud our logic. For example, a practitioner may overvalue the first data encountered, skewing their thinking. Another example may be where the practitioner recalls a recent or dramatic case that quickly comes to mind, coloring the practitioner’s judgement. Another pitfall is where stereotypes may prejudice thinking.^[54] Pat Croskerry describes clinical reasoning as an interplay between intuitive, subconscious thought (System 1) and deliberate, conscious rational consideration (System 2). In this framework, many cognitive errors reflect over-reliance on System 1 processing, although cognitive errors may also sometimes involve System 2.^[55]

Sleep deprivation has also been cited as a contributing factor in medical errors.^[13] One study found that being awake for over 24 hours caused medical interns to double or triple the number of preventable medical errors, including those that resulted in injury or death.^[56] The risk of car crash after these shifts increased by 168%, and the risk of near miss by 460%.^[57] Interns admitted falling asleep during lectures, during rounds, and even during surgeries.^[57] Night shifts are associated with worse surgeon performance during laparoscopic surgeries.^[13]

Practitioner risk factors include fatigue,^[58][59][60]
depression,^[61] and burnout.^[62]
Factors related to the clinical setting include diverse patients, unfamiliar settings, time pressures, and increased patient-to-nurse staffing ratio increases.^[63]
Drug names that look alike or sound alike are also a problem.^[64]

Errors in interpreting medical images are often perceptual instead of «fact-based»; these errors are often caused by failures of attention or vision.^[65] For example, visual illusions can cause radiologists to misperceive images.^[66]

A number of Information Technology (IT) systems have been developed to detect and prevent medication errors, the most common type of medical errors.^[67] These systems screen data such as ICD-9 codes, pharmacy and laboratory data. Rules are used to look for changes in medication orders, and abnormal laboratory results that may be indicative of medication errors and/or adverse drug events.^[68]

Examples[edit]

Errors can include misdiagnosis or delayed diagnosis, administration of the wrong drug to the wrong patient or in the wrong way, giving multiple drugs that interact negatively, surgery on an incorrect site, failure to remove all surgical instruments, failure to take the correct blood type into account, or incorrect record-keeping. A 10th type of error is ones which are not watched for by researchers, such as RNs failing to program an IV pump to give a full dose of IV antibiotics or other medication.

Errors in diagnosis[edit]

According to a 2016 study from Johns Hopkins Medicine, medical errors are the third-leading cause of death in the United States.^[69] The projected cost of these errors to the U.S. economy is approximately $20 billion, 87% of which are direct increases in medical costs of providing services to patient affected by medical errors.^[70] Medical errors can increase average hospital costs by as much as $4,769 per patient.^[71] One common type of medical error stems from x-rays and medical imaging: failing to see or notice signs of disease on an image.^[65] The retrospective «miss» rate among abnormal imaging studies is reported to be as high as 30% (the real-life error rate is much lower, around 4-5%, because not all images are abnormal),^[72] and up to 20% of missed findings result in long-term adverse effects.^[73][74]

A large study reported several cases where patients were wrongly told that they were HIV-negative when the physicians erroneously ordered and interpreted HTLV (a closely related virus) testing rather than HIV testing. In the same study, >90% of HTLV tests were ordered erroneously.^[75]
It is estimated^{[by whom?]} that between 10 and 15% of physician diagnoses are erroneous.^[76]

Misdiagnosis of lower extremity cellulitis is estimated to occur in 30% of patients, leading to unnecessary hospitalizations in 85% and unnecessary antibiotic use in 92%. Collectively, these errors lead to between 50,000 and 130,000 unnecessary hospitalizations and between $195 and $515 million in avoidable health care spending annually in the United States.^[77]

Misdiagnosis of psychological disorders[edit]

Female sexual desire sometimes used to be diagnosed as female hysteria.^{[citation needed]}

Sensitivities to foods and food allergies risk being misdiagnosed as the anxiety disorder orthorexia.

Studies have found that bipolar disorder has often been misdiagnosed as major depression. Its early diagnosis necessitates that clinicians pay attention to the features of the patient’s depression and also look for present or prior hypomanic or manic symptomatology.^[78]

The misdiagnosis of schizophrenia is also a common problem. There may be long delays of patients getting a correct diagnosis of this disorder.^[79]

Delayed sleep phase disorder is often confused with: psychophysiological insomnia; depression; psychiatric disorders such as schizophrenia, ADHD or ADD; other sleep disorders; or school refusal. Practitioners of sleep medicine point out the dismally low rate of accurate diagnosis of the disorder, and have often asked for better physician education on sleep disorders.^[80]

Cluster headaches are often misdiagnosed, mismanaged, or undiagnosed for many years; they may be confused with migraine, «cluster-like» headache (or mimics), CH subtypes, other TACs ( trigeminal autonomic cephalalgias), or other types of primary or secondary headache syndrome.^[81] Cluster-like head pain may be diagnosed as secondary headache rather than cluster headache.^[82] Under-recognition of CH by health care professionals is reflected in consistent findings in Europe and the United States that the average time to diagnosis is around seven years.^[83]

Asperger syndrome and autism tend to get undiagnosed or delayed recognition and delayed diagnosis^[84][85] or misdiagnosed.^[86] Delayed or mistaken diagnosis can be traumatic for individuals and families; for example, misdiagnosis can lead to medications that worsen behavior.^[87][88]

The DSM-5 field trials included «test-retest reliability» which involved different clinicians doing independent evaluations of the same patient—a new approach to the study of diagnostic reliability.^[89]

Outpatient vs. inpatient[edit]

Misdiagnosis is the leading cause of medical error in outpatient facilities.
Since the National Institute of Medicine’s 1999 report, «To Err is Human,» found up to 98,000 hospital patients die from preventable medical errors in the U.S. each year, government and private sector efforts have focused on inpatient safety.

Medical prescriptions[edit]

While in 2000 the Committee on Quality of Health Care in America affirmed medical mistakes are an «unavoidable outcome of learning to practice medicine»,^[90] at 2019 the commonly accepted link between prescribing skills and clinical clerkships was not yet demonstrated by the available data^[91] and in the U.S. legibility of handwritten prescriptions has been indirectly responsible for at least 7,000 deaths annually.^[92]

Prescription errors concern ambiguous abbreviations, the right spelling of the full name of drugs: improper use of the nomenclature, of decimal points, unit or rate expressions; legibility and proper instructions; miscalculations of the posology (quantity, route and frequency of administration, duration of the treatment, dosage form and dosage strength); lack of information about patients (e.g. allergy, declining renal function) or reported in the medical document.^[91] There were an estimated 66 million clinically significant medication errors in the British NHS in 2018. The resulting adverse drug reactions are estimated to cause around 700 deaths a year in England and to contribute to around 22,000 deaths a year. The British researchers did not find any evidence that error rates were lower in other countries, and the global cost was estimated at $42 billion per year.^[93]

Medication errors in hospital include omissions, delayed dosing and incorrect medication administrations. Medication errors are not always readily identified, but can be reported using case note reviews or incident reporting systems.^[94] There are pharmacist-led interventions that can reduce the incident of medication error.^[95] Electronic prescribing has been shown to reduce prescribing errors by up to 30%.^[96]

After an error has occurred[edit]

Mistakes can have a strongly negative emotional impact on the doctors who commit them.^{[97][98][99][100]}

Recognizing that mistakes are not isolated events[edit]

Some physicians recognize that adverse outcomes from errors usually do not happen because of an isolated error and actually reflect system problems.^[49] This concept is often referred to as the Swiss Cheese Model.^[101] This is the concept that there are layers of protection for clinicians and patients to prevent mistakes from occurring. Therefore, even if a doctor or nurse makes a small error (e.g. incorrect dose of drug written on a drug chart by doctor), this is picked up before it actually affects patient care (e.g. pharmacist checks the drug chart and rectifies the error).^[101] Such mechanisms include:
Practical alterations (e.g.-medications that cannot be given through IV, are fitted with tubing which means they cannot be linked to an IV even if a clinician makes a mistake and tries to),^[102] systematic safety processes (e.g. all patients must have a Waterlow score assessment and falls assessment completed on admission),^[102] and training programmes/continuing professional development courses^[102] are measures that may be put in place.

There may be several breakdowns in processes to allow one adverse outcome.^[103] In addition, errors are more common when other demands compete for a physician’s attention.^{[104][105][106]} However, placing too much blame on the system may not be constructive.^[49]

Placing the practice of medicine in perspective[edit]

Essayists imply that the potential to make mistakes is part of what makes being a physician rewarding and without this potential the rewards of medical practice would be diminished. Laurence states that «Everybody dies, you and all of your patients. All relationships end. Would you want it any other way? […] Don’t take it personally»^[107]
Seder states «[…] if I left medicine, I would mourn its loss as I’ve mourned the passage of my poetry. On a daily basis, it is both a privilege and a joy to have the trust of patients and their families and the camaraderie of peers. There is no challenge to make your blood race like that of a difficult case, no mind game as rigorous as the challenging differential diagnosis, and though the stakes are high, so are the rewards.»^[108]

Disclosing mistakes[edit]

Forgiveness, which is part of many cultural traditions, may be important in coping with medical mistakes.^[109] Among other healing processes, it can be accomplished through the use of communicative disclosure guidelines.^[110]

To oneself[edit]

Inability to forgive oneself may create a cycle of distress and increased likelihood of a future error.^[111]

However, Wu et al. suggest «…those who coped by accepting responsibility were more likely to make constructive changes in practice, but [also] to experience more emotional distress.»^[112] It may be helpful to consider the much larger number of patients who are not exposed to mistakes and are helped by medical care.^[108]

To patients[edit]

Gallagher et al. state that patients want «information about what happened, why the error happened, how the error’s consequences will be mitigated, and how recurrences will be prevented.»^[113] Interviews with patients and families reported in a 2003 book by Rosemary Gibson and Janardan Prasad Singh, put forward that those who have been harmed by medical errors face a «wall of silence» and «want an acknowledgement» of the harm.^[114] With honesty, «healing can begin not just for the patients and their families but also the doctors, nurses and others involved.» In a line of experimental investigations, Annegret Hannawa et al. developed evidence-based disclosure guidelines under the scientific «Medical Error Disclosure Competence (MEDC)» framework.^[110][115]

A 2005 study by Wendy Levinson of the University of Toronto showed surgeons discussing medical errors used the word «error» or «mistake» in only 57 percent of disclosure conversations and offered a verbal apology only 47 percent of the time.^[116]

Patient disclosure is important in the medical error process. The current standard of practice at many hospitals is to disclose errors to patients when they occur. In the past, it was a common fear that disclosure to the patient would incite a malpractice lawsuit. Many physicians would not explain that an error had taken place, causing a lack of trust toward the healthcare community. In 2007, 34 states passed legislation that precludes any information from a physician’s apology for a medical error from being used in malpractice court (even a full admission of fault).^[117] This encourages physicians to acknowledge and explain mistakes to patients, keeping an open line of communication.

The American Medical Association’s Council on Ethical and Judicial Affairs states in its ethics code:

«Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all facts necessary to ensure understanding of what has occurred. Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.»

From the American College of Physicians Ethics Manual:^[118]

«In addition, physicians should disclose to patients information about procedural or judgment errors made in the course of care if such information is material to the patient’s well-being. Errors do not necessarily constitute improper, negligent, or unethical behavior, but failure to disclose them may.»

However, «there appears to be a gap between physicians’ attitudes and practices regarding error disclosure. Willingness to disclose errors was associated with higher training level and a variety of patient-centered attitudes, and it was not lessened by previous exposure to malpractice litigation».^[119] Hospital administrators may share these concerns.^[120]

Consequently, in the United States, many states have enacted laws excluding expressions of sympathy after accidents as proof of liability.

Disclosure may actually reduce malpractice payments.^[121][122]

To non-physicians[edit]

In a study of physicians who reported having made a mistake, it was offered that disclosing to non-physician sources of support may reduce stress more than disclosing to physician colleagues.^[123] This may be due to the finding that of the physicians in the same study, when presented with a hypothetical scenario of a mistake made by another colleague, only 32% of them would have unconditionally offered support. It is possible that greater benefit occurs when spouses are physicians.^[124]

To other physicians[edit]

Discussing mistakes with other physicians is beneficial.^[49] However, medical providers may be less forgiving of one another.^[124] The reason is not clear, but one essayist has admonished, «Don’t Take Too Much Joy in the Mistakes of Other Doctors.»^[125]

To the physician’s institution[edit]

Disclosure of errors, especially ‘near misses’ may be able to reduce subsequent errors in institutions that are capable of reviewing near misses.^[126] However, doctors report that institutions may not be supportive of the doctor.^[49]

Use of rationalization to cover up medical errors[edit]

Based on anecdotal and survey evidence, Banja^[127] states that rationalization (making excuses) is very common among the medical profession to cover up medical errors.

By potential for harm to the patient[edit]

In a survey of more than 10,000 physicians in the United States, when asked the question, «Are there times when it’s acceptable to cover up or avoid revealing a mistake if that mistake would not cause harm to the patient?», 19% answered yes, 60% answered no and 21% answered it depends. On the question, «Are there times when it is acceptable to cover up or avoid revealing a mistake if that mistake would potentially or likely harm the patient?», 2% answered yes, 95% answered no and 3% answered it depends.^[128]

Cause-specific preventive measures[edit]

Traditionally, errors are attributed to mistakes made by individuals, who then may be penalized. A common approach to respond to and prevent specific errors is requiring additional checks at particular points in the system, whose findings and detail of execution must be recorded. As an example, an error of free flow IV administration of heparin is approached by teaching staff how to use the IV systems and to use special care in setting the IV pump. While overall errors become less likely, the checks add to workload and may in themselves be a cause of additional errors. In some hospitals, a regular morbidity and mortality conference meeting is scheduled to discuss complications or deaths and learn from or improve the overall processes.

A newer model for improvement in medical care takes its origin from the work of W. Edwards Deming in a model of Total Quality Management. In this model, there is an attempt to identify the underlying system defect that allowed the error to occur. As an example, in such a system the error of free flow IV administration of heparin is dealt with by not using IV heparin and substituting subcutaneous administration of heparin, obviating the entire problem. However, such an approach presupposes available research showing that subcutaneous heparin is as effective as IV. Thus, most systems use a combination of approaches to the problem.

In specific specialties[edit]

The field of medicine that has taken the lead in systems approaches to safety is anaesthesiology.^[129] Steps such as standardization of IV medications to 1 ml doses, national and international color-coding standards, and development of improved airway support devices has the field a model of systems improvement in care.

Pharmacy professionals have extensively studied the causes of errors in the prescribing, preparation, dispensing and administration of medications. As far back as the 1930s, pharmacists worked with physicians to select, from many options, the safest and most effective drugs available for use in hospitals.^[130] The process is known as the Formulary System and the list of drugs is known as the Formulary. In the 1960s, hospitals implemented unit dose packaging and unit dose drug distribution systems to reduce the risk of wrong drug and wrong dose errors in hospitalized patients;^[131] centralized sterile admixture services were shown to decrease the risks of contaminated and infected intravenous medications;^[132][133] and pharmacists provided drug information and clinical decision support directly to physicians to improve the safe and effective use of medications.^[134] Pharmacists are recognized experts in medication safety and have made many contributions that reduce error and improve patient care over the last 50 years. More recently, governments have attempted to address issues like patient-pharmacist communication and consumer knowledge through measures like the Australian Government’s Quality Use of Medicines policy.

Legal procedure[edit]

Standards and regulations for medical malpractice vary by country and jurisdiction within countries. Medical professionals may obtain professional liability insurances to offset the risk and costs of lawsuits based on medical malpractice.

Prevention[edit]

Medical care is frequently compared adversely to aviation; while many of the factors that lead to errors in both fields are similar, aviation’s error management protocols are regarded as much more effective.^[135] Safety measures include informed consent, the availability of a second practitioner’s opinion, voluntary reporting of errors, root cause analysis, reminders to improve patient medication adherence, hospital accreditation, and systems to ensure review by experienced or specialist practitioners.^[136]

A template has been developed for the design (both structure and operation) of hospital medication safety programmes, particularly for acute tertiary settings,^[137] which emphasizes safety culture, infrastructure, data (error detection and analysis), communication and training.

Particularly to prevent the medication errors in the perspective of the intrathecal administration of local anaesthetics, there is a proposal to change the presentation and packaging of the appliances and agents used for this purpose. One spinal needle with a syringe prefilled with the local anaesthetic agents may be marketed in a single blister pack, which will be peeled open and presented before the anaesthesiologist conducting the procedure.^[138]

Physician well-being has also been recommended as an indicator of healthcare quality given its association with patient safety outcomes.^[139] A meta-analysis involving 21517 participants found that physicians with depressive symptoms had a 95% higher risk of reporting medical errors and that the association between physician depressive symptoms and medical errors is bidirectional ^[61]

Reporting requirements[edit]

In the United States, adverse medical event reporting systems were mandated in just over half (27) of the states as of 2014, a figure unchanged since 2007.^[140][141] In U.S. hospitals error reporting is a condition of payment by Medicare.^[142] An investigation by the Office of Inspector General, Department of Health and Human Services released January 6, 2012 found that most errors are not reported and even in the case of errors that are reported and investigated changes are seldom made which would prevent them in the future. The investigation revealed that there was often lack of knowledge regarding which events were reportable and recommended that lists of reportable events be developed.^[143]

Misconceptions[edit]

Some common misconceptions about medical error include:

• Medical error is the «third leading cause of death» in the United States. This canard stems from an erroneous 2016 study which, according to David Gorski, «has taken on a life of its own» and fuelled «a myth promulgated by both quacks and academics».^[144]
• «Bad apples» or incompetent health care providers are a common cause. (Although human error is commonly an initiating event, the faulty care delivery process invariably permits or compounds the harm and so is the focus of improvement.)^[12]
• High-risk procedures or medical specialties are responsible for most avoidable adverse events. (Although some mistakes, such as in surgery, are harder to conceal, errors occur in all levels of care.^[12] Even though complex procedures entail more risk, adverse outcomes are not usually due to error, but to the severity of the condition being treated.)^[42][145] However, United States Pharmacopeia has reported that medication errors during the course of a surgical procedure are three times more likely to cause harm to a patient than those occurring in other types of hospital care.^[43]
• If a patient experiences an adverse event during the process of care, an error has occurred. (Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from the treatment itself.)^[10]

See also[edit]

References[edit]

Further reading[edit]

• Gawande, Atul (2002). Complications: A Surgeon’s Notes on an Imperfect Science. New York: Metropolitan Books. ISBN 978-0-8050-6319-6.
• Wachter, Robert; Shojania, Kaveh (2004). Internal Bleeding: The Truth Behind America’s Terrifying Epidemic of Medical Mistakes. New York: Rugged Land. ISBN 978-1-59071-016-6.
• Banja, John (2005). Medical Errors and Medical Narcissism. Boston: Jones and Bartlett. ISBN 978-0-7637-8361-7.
• Porter, Michael E.; Olmsted Teisberg, Elizabeth (2006). Redefining Health Care: Creating Value-Based Competition on Results. Boston: Harvard Business School Press. ISBN 978-1-59139-778-6.
• Gibson, Rosemary; Prasad Singh, Janardan (2003). Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans. Washington D.C.: Regnery. ISBN 978-0-89526-112-0.
• Alldred D.P.; Standage C.; Zermansky A.G.; Jesson B.; Savage I.; Franklin B.D.; Barber N.; Raynor D.K. (2008). «Development and validation of criteria to identify medication-monitoring errors in care home residents». International Journal of Pharmacy Practice. 16 (5): 317–323. doi:10.1211/ijpp.16.5.0007. S2CID 71701489.
• Committee on Identifying and Preventing Medication Errors; Board on Health Care Services (2007). Preventing medication errors. National Academies Press. ISBN 978-0-309-10147-9.
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